Shares of Novo Nordisk, the Danish company that has a manufacturing facility in Clayton, fell 14 percent Monday after federal regulators denied approval of its insulin drug Tresiba.
The Copenhagen-based company said Sunday that it had received a Complete Response Letter from the Food and Drug Administration, which is what the agency issues when its review process is complete and a drug application is not ready for approval.
The FDA is requesting additional data to evaluate the drugs’ potential cardiovascular risks.
The decision also applies to Novo Nordisk’s new drug application for Ryzodeg, a related insulin product, that would also act as a treatment for type 1 and 2 diabetes.
The agency also said in its letter that the drugs can’t be approved until violations cited in a previous warning letter, issued Dec. 12, have been resolved.
Novo Nordisk doesn’t expect to be able to provide the additional cardiovascular data the agency is requesting by the end of this year.
“We are surprised and disappointed to receive this letter, but we acknowledge this decision by the FDA and will work with the agency to determine the best path forward to completing the review,” Lars Rebien Sorensen, Novo Nordisk’s CEO, said in a statement.
The FDA’s decision came as a bit of a surprise in part because an agency advisory panel in November voted 8-4 to recommend approval of the drugs.
Tresiba and Ryzodeg have already been approved in Japan, the European Union and Mexico.
Novo Nordisk said it doesn’t expect the FDA’s decision to “significantly impact Novo Nordisk’s expectations for the company’s financial results for 2013.”
Novo Nordisk employs more than 500 in Clayton, where it makes insulin.
The company’s shares closed at $165.40 on Monday, down $26.89.
Staff writer David Bracken